Drugs with Mechanism of Action Utilized by Namodenoson Are Recommended by Leading U.S. Researchers to Be Developed to Combat Liver Cancer

A Phase II study in patients with advanced liver cancer
(hepatocellular carcinoma) is currently ongoing with Namodenoson and
completed patients’ enrollment

Namodenoson has an Orphan Drug Designation in Europe and the U.S.,
as well as Fast Track Status in the U.S.

PETACH TIKVA, Israel--(BUSINESS WIRE)--
Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology
company advancing a pipeline of proprietary small molecule drugs that
address cancer, liver and inflammatory diseases, today announced that
U.S. researchers published scientific findings recommending development
of anti-Liver Cancer Drugs based on a mechanism of action utilized by
Namodenoson.

Can-Fite extensively published that its anti-cancer drug candidate,
Namodenoson, inhibits a specific molecular signaling pathway in the
liver cancer cells, designated as the Wnt/β-catenin, and is responsible
for the development and progression of hepatocellular carcinoma (HCC).
The scientific article published on June 28, 2018 by key opinion leaders
from the University of Texas MD Anderson Cancer Center, Houston, TX,
USA, recommends that targeting and inhibiting the very same
Wnt/β-catenin pathway leads to an anti-cancer effect against
hepatocellular carcinoma (Role of Wnt/β catenin signaling in
hepatocellular carcinoma pathogenesis and clinical significance;
Authors: Khalaf AM, Fuentes D, Morshid AI, Burke MR, Kaseb AO, Hassan M,
Hazle JD, Elsayes KM. https://www.dovepress.com/article_39060.t87482447)

“We are very excited to read the MD Anderson group article which we
consider as important validation of Can-Fite’s scientific approach to
the development of Namodenoson for the treatment of liver cancer. We’re
proud to be working in the forefront of research of HCC with our orally
available drug Namodenoson with its unique mechanism of action as an
anti-cancer agent and its favorable safety profile. We look forward to
data release from our ongoing Phase II advanced liver cancer trial,”
stated Can-Fite CEO Dr. Pnina Fishman.

The currently ongoing global Phase II study is being conducted in the
U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who
failed Nexavar (sorafenib) as a first line treatment are treated twice
daily with 25mg of oral Namodenoson or placebo using a 2:1
randomization. The primary endpoint of the Phase II study is Overall
Survival (OS). Secondary endpoints include Progression Free Survival
(PFS), safety, and the relationship between outcomes and A3AR expression.

Accumulated safety data to date continues to indicate a favorable safety
profile, with no clinically significant novel or emerging events
attributed to chronic treatment with Namodenoson.

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and
the U.S., as well as Fast Track Status in the U.S. as a second line
treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high
affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson is being evaluated in Phase II trials for two indications,
as a second line treatment for hepatocellular carcinoma, and as a
treatment for non-alcoholic fatty liver disease (NAFLD) and
non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in
diseased cells whereas low expression is found in normal cells. This
differential effect accounts for the excellent safety profile of the
drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multi-billion dollar markets in
the treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is currently in a Phase
III trial for rheumatoid arthritis and is expected to enter a Phase III
trial for psoriasis in 2018. Can-Fite's liver cancer drug, Namodenoson,
is in Phase II trials for hepatocellular carcinoma (HCC), the most
common form of liver cancer, and for the treatment of non-alcoholic
steatohepatitis (NASH). Namodenoson has been granted Orphan Drug
Designation in the U.S. and Europe and Fast Track Designation as a
second line treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat other
cancers including colon, prostate, and melanoma. CF602, the Company's
third drug candidate, has shown efficacy in the treatment of erectile
dysfunction in preclinical studies and the Company is investigating
additional compounds, targeting A3AR, for the treatment of sexual
dysfunction. These drugs have an excellent safety profile with
experience in over 1,000 patients in clinical studies to date. For more
information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about
Can-Fite's expectations, beliefs or intentions regarding, among other
things, market risks and uncertainties, its product development efforts,
business, financial condition, results of operations, strategies or
prospects. In addition, from time to time, Can-Fite or its
representatives have made or may make forward-looking statements, orally
or in writing. Forward-looking statements can be identified by the use
of forward-looking words such as "believe," "expect," "intend," "plan,"
"may," "should" or "anticipate" or their negatives or other variations
of these words or other comparable words or by the fact that these
statements do not relate strictly to historical or current matters.
These forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or with
the approval of one of Can-Fite's authorized executive officers.
Forward-looking statements relate to anticipated or expected events,
activities, trends or results as of the date they are made. Because
forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that
could cause Can-Fite's actual results to differ materially from any
future results expressed or implied by the forward-looking statements.
Many factors could cause Can-Fite's actual activities or results to
differ materially from the activities and results anticipated in such
forward-looking statements. Factors that could cause our actual results
to differ materially from those expressed or implied in such
forward-looking statements include, but are not limited to: the
initiation, timing, progress and results of our preclinical studies,
clinical trials and other product candidate development efforts; our
ability to advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials; our
receipt of regulatory approvals for our product candidates, and the
timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain corporate
collaborations; the implementation of our business model and strategic
plans for our business and product candidates; the scope of protection
we are able to establish and maintain for intellectual property rights
covering our product candidates and our ability to operate our business
without infringing the intellectual property rights of others; estimates
of our expenses, future revenues, capital requirements and our needs for
additional financing; competitive companies, technologies and our
industry; statements as to the impact of the political and security
situation in Israel on our business; and risks and other risk factors
detailed in Can-Fite's filings with the SEC and in its periodic filings
with the TASE. In addition, Can-Fite operates in an industry sector
where securities values are highly volatile and may be influenced by
economic and other factors beyond its control. Can-Fite does not
undertake any obligation to publicly update these forward-looking
statements, whether as a result of new information, future events or
otherwise.